arGentis Pharmaceuticals, LLC today announced that it will collaborate with the University of Tennessee Health Science Center (UTHSC) and the Veterans Affairs Medical Center of Memphis (VAMC) to initiate the first human clinical evaluation of an oral altered peptide ligand (APL), ARG301, in a Phase I study of Rheumatoid Arthritis patients. ARG301 is a synthetic peptide, which in animal studies appears to down regulate autoimmunity to Type II collagen (CII), a known autoantigen in RA. Investigators at the UTHSC and Memphis VAMC developed the therapy and have received a Clinical Merit Review Grant from the Department of Veterans Affairs to conduct the trial.
“Due to its unique mechanism of action and compelling preclinical data, we are hopeful that ARG301 will offer a novel therapeutic approach for rheumatoid arthritis,” said Tom I. Davis, II, Chief Executive Officer of arGentis. “In continuing our partnership with UTHSC and University of Tennessee Research Foundation, arGentis is very pleased to add this promising oral therapeutic consistent with our autoimmunity R&D approach.”
Research in animal models suggests APLs (Altered Peptide Ligands) are effective in preventing and ameliorating tissue-specific autoimmune diseases. Trials of APLs administered intravenously or subcutaneously in human autoimmune disease have had mixed results. None of these trials, however, incorporated a pre-selection step to test the ability in vitro of the APL, to down regulate Th1 response by patient’s peripheral blood mononuclear cells (PBMC) stimulated by a disease-specific autoantigen such as CII in RA patients.